Job Overview
Lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide support to management with insights, analyses and assessment and promotion of compliance with regulations, guidelines, and operating procedures through risk identification and mitigation, and improvement initiatives . Manage the quality assurance oversight of quality issues, audit responses, assignments, training and staff. Oversee and lead team management activities.
Essential Functions
Lead and mentor members of the CAPA management team, with a focus on driving improvement and compliance, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines and providing support as needed.
Lead and support CAPA activities for complex QIs and sponsor audits and inspections: assessing investigations, ensuring appropriate root cause analysis is performed, adequate corrective and preventative actions and effectiveness are implemented and followed up within the agreed timelines
Collaborate with cross-functional stakeholders to identify process gaps, areas of improvements and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements
Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and that robust corrective and preventative actions and effectiveness checks are tracked and completed within the required timelines
Promote a culture of proactive and continuous process improvement by identifying risks and trends, and optimizing the CAPA system and processes.
Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff.
Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, good documentation practices, and compliance adherence
Develop and/or improve governing procedures, templates and work instructions, in order to streamline processes and drive compliance
Advise Quality Assurance management on system audit needs.
Support external and internal audits and inspections of IQVIA including inspections of IQVIA or investigational sites where needed, and ensure a state of inspection readiness at all times
Qualifications
Bachelor's Degree
Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials is a must
Prior experience in audit and inspection management/support
Root cause analysis and quality investigations
Able to independently manage complex quality issues with minimal supervision
Experience reviewing and driving CAPAs to closure
7 years Quality Assurance experience in pharmaceutical, technical, or related area with a focus on GCP in Clinical Trials.
Background in science, healthcare and/or other relevant discipline and a detailed understanding of the clinical trial process and GCP guidelines
Possess strong leadership and organizational skills for prioritizing workload and responsibilities.
Excellent problem solving and root cause analysis skills.
Excellent training and mentoring capabilities.
Ability to handle multiple projects and work independently and effectively in a fast-paced changing environment
Ability to speak effectively one-to-one, in group settings, with clients, vendors and employees of the organization.
Proficient in Microsoft Office applications (Word, Excel)
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.